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Patients receive iodine I 124 monoclonal antibody M5A IV on day 0 and undergo PET scan on days 2 and 6.

Iodine I 124 Monoclonal Antibody M5A

Positron Emission Tomography

Savita V Dandapani

This phase I trial studies how well an imaging agent called I-124 M5A works in detecting CEA-positive colorectal cancer that has spread to the liver. I-124 M5A is a monoclonal antibody, called M5A, linked to a radioactive substance called I-124. M5A binds to CEA-positive cancer cells and may, through imaging scans, be able to detect liver metastases by picking up signals from I-124.

PRIMARY OBJECTIVES:

I. To determine the ability of iodine I 124 monoclonal antibody M5A (124I-labeled M5A monoclonal antibody \[MAb\]) to localize to CEA positive gastrointestinal (GI) metastases primarily focused on the liver.

SECONDARY OBJECTIVES:

I. To determine the safety and pharmacokinetics of administration of 124I-labeled M5A MAb.

II. To correlate the radiographic positron emission tomography (PET) images to the liver metastases pathology.

III. To assess if the I-124 imaging agent detected additional liver and additional extra-hepatic liver lesions not appreciated on standard imaging scans.

OUTLINE:

Patients receive iodine I 124 monoclonal antibody M5A intravenously (IV) on day 0 and undergo PET scan on days 2 and 6.

After completion of study, patients are followed up periodically for 1 year.

An Imaging Agent (I-124 M5A) in Detecting CEA-Positive Liver Metastases in Patients With Colorectal Cancer

Pilot Study: Detection of Colorectal Metastatic Liver Disease Preoperatively Using 124I-Labeled M5A Monoclonal Antibody to Carcinoembryonic Antigen (CEA)

Will be observed using standard imaging scans obtained pre-operatively and to assess if the antibody detects new liver metastases. Serum concentration data will be tabulated and descriptive statistics computed.

percent of patients with pathological confirmation of liver metastases

percent of patients with suspicious extra-hepatic lesions (both previously noted or new) identified on I-124 M5A but were not identified on standard imaging

Will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Safety data will be displayed and abnormal laboratory values reported. The frequency of adverse events will be tabulated by body system.

National Cancer Institute (NCI)

City of Hope Medical Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
An Imaging Agent (I-124 M5A) in Detecting CEA-Positive Liver Metastases in Patients With Colorectal Cancer	NCT03993327	Colorectal Carc... Metastatic Colo... Stage IV Colore... Stage IVA Color... Stage IVB Color... Stage IVC Color...	Iodine I 124 Mo... Positron Emissi...	18 Years -	City of Hope Medical Center
An Imaging Agent (I-124 M5A) in Detecting CEA-Positive Liver Metastases in Patients With Colorectal Cancer	NCT03993327	Colorectal Carc... Metastatic Colo... Stage IV Colore... Stage IVA Color... Stage IVB Color... Stage IVC Color...	Iodine I 124 Mo... Positron Emissi...	18 Years -	City of Hope Medical Center

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